CARCINOEMBRYONIC ANTIGEN (CEA)
Received Oct 8, 2015 · Event occurred Sep 24, 2015
Report 1823260-2015-04301 · MDR key 5137687
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11731629322
Lot number
180801
Product problems
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER QUESTIONED RESULTS FROM 1 PATIENT SAMPLE TESTED FOR CARCINOEMBRYONIC ANTIGEN (CEA) ON AN ARCHITECT ANALYZER AND A LUMIPULSE ANALYZER. THE CUSTOMER REQUESTED THE SAMPLE BE INVESTIGATED TO CHECK FOR AN INTERFERENCE. UPON COMPLETING THE INVESTIGATION, ERRONEOUS CEA RESULTS WERE IDENTIFIED BETWEEN THE E411 ANALYZER USED AT THE INVESTIGATION SITE AND THE LUMIPULSE ANALYZER. THE DATE OF TESTS PERFORMED AT THE CUSTOMER SITE IS NOT KNOWN. THE RESULTS FROM THE INVESTIGATION WILL BE REPORTED TO THE CUSTOMER. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHED DATA FOR PATIENT RESULTS. NO ADVERSE EVENT WAS REPORTED. THE E411 ANALYZER SERIAL NUMBER WAS NOT PROVIDED. BASED ON THE INVESTIGATION RESULTS, A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE ARCHITECT ANALYZER RESULT WAS REPRODUCIBLE USING THE E411 ANALYZER. IT IS NOT KNOWN WHY THE LUMIPULSE ANALYZER RESULT WAS SO MUCH LOWER. THERE WAS NO INDICATION OF HUMAN ANTI-MOUSE ANTIBODY (HAMA) INTERFERENCE.